Patient Satisfaction With Oral vs Intravenous Sedation for Vitrectomy Surgery: A Randomized, Noninferiority Clinical Trial

2021 ◽  
pp. 247412642110278
Author(s):  
Nicole H. Siegel ◽  
Marissa G. Fiorello ◽  
Steven Ness ◽  
Jiwoo Kim ◽  
Viha Vig ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Patient Satisfaction ◽  
Intraoperative Complications ◽  
A Priori ◽  
Intravenous Sedation ◽  
Patient Satisfaction Scores ◽  
Oral Sedation ◽  
To Receive ◽  
Vitrectomy Surgery ◽  
Noninferiority Margin

Purpose: This work aims to determine whether patient satisfaction with oral sedation is noninferior to intravenous (IV) sedation in vitrectomy surgery. Methods: This prospective, randomized, double-masked, noninferiority clinical trial measured patient satisfaction in 84 participants receiving oral or IV sedation during vitrectomy surgery under monitored anesthesia care. Patients were excluded if they were unable to receive benzodiazepines. Results: The primary outcome was patient satisfaction. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications. Among the 84 patients (46 [54.8%] men; mean [SD] age, 57.0 [12.7 years]), mean patient satisfaction scores were 5.22 ± 0.81 (range, 3.08-6; scale 1-6) with oral and 5.25 ± 0.63 (range, 3.83-6; scale 1-6) with IV sedation. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the groups of 0.03 (1-tailed 95% CI, infinity to 0.29), our results demonstrated the noninferiority of oral sedation ( P = .002). There were no significant differences in surgeon or anesthesia satisfaction or major intraoperative complications. Five patients receiving oral (11.9%) and 3 receiving IV (7.1%) sedation required supplemental IV sedation (difference, 4.8%; P = .46). Conclusions: Patient satisfaction for oral sedation was noninferior to IV sedation for vitrectomy surgery.

scholarly journals Transnasal Humidified Rapid Insufflation Ventilatory Exchange With Nasopharyngeal Airway Facilitates Apneic Oxygenation: A Randomized Clinical Noninferiority Trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Lingke Chen ◽  
Liu Yang ◽  
Weitian Tian ◽  
Xiao Zhang ◽  
Yanhua Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lower Boundary ◽  
Clinical Trial Registration ◽  
Apneic Oxygenation ◽  
Nasopharyngeal Airway ◽  
Airway Opening ◽  
The Difference ◽  
To Receive ◽  
Noninferiority Margin ◽  
Upper Boundary

Background: Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) was used to extend the safe apnea time. However, THRIVE is only effective in patients with airway opening. Nasopharyngeal airway (NPA) is a simple device that can help to keep airway opening. This study aimed to investigate the noninferiority of NPA to jaw thrust for airway opening during anesthesia-induced apnea.Methods: This was a prospective randomized single-blinded noninferiority clinical trial on the use of THRIVE in patients with anesthesia-induced apnea. The participants were randomly allocated to receive NPA or jaw thrust. The primary outcomes were PaO2 and PaCO2 at 20 min after apnea, with noninferiority margin criteria of −6.67 and 0.67 kPa, respectively.Results: A total of 123 patients completed the trial: 61 in the NPA group and 62 in the jaw thrust group. PaO2 at 20 min after apnea was 42.9 ± 14.0 kPa in the NPA group and 42.7 ± 13.6 kPa in the jaw thrust group. The difference between these two means was 0.25 kPa (95% CI, −3.87 to 4.37 kPa). Since the lower boundary of the 95% CI was > −6.67 kPa, noninferiority was established because higher PO2 is better. PaCO2 at 20 min after apnea was 10.74 ± 1.09 kPa in the NPA group and 10.54 ± 1.18 kPa in the jaw thrust group. The difference between the two means was 0.19 kPa (95% CI, −0.14 to 0.53 kPa). Since the upper boundary of the 95% CI was <0.67 kPa, noninferiority was established because lower PCO2 is better. No patient had a SpO2 < 90% during apnea.Conclusion: When THRIVE was applied during anesthesia-induced apnea, NPA placement kept airway opening and was noninferior to jaw thrust in terms of its effects on PaO2 and PaCO2 at 20 min after apnea.Clinical Trial Registration:ClinicalTrials.gov (NCT03741998).

scholarly journals Development of a combined paediatric emergency department and observation unit

2020 ◽  
Vol 9 (1) ◽  
pp. e000688
Author(s):  
Czer Anthoney Enriquez Lim ◽  
Julie Oh ◽  
Erick Eiting ◽  
Catherine Coughlin ◽  
Yvette Calderon ◽  
...  
Keyword(s):  
Emergency Department ◽  
Quality Improvement ◽  
Patient Satisfaction ◽  
Patient Outcomes ◽  
Close Monitoring ◽  
Observation Unit ◽  
Paediatric Emergency Department ◽  
Paediatric Emergency ◽  
Patient Satisfaction Scores ◽  
Conversion Rates

BackgroundRecent trends towards more cost-efficient and patient-centred treatment are converging to provide opportunities to improve the care of children. Observation units are hospital areas dedicated to the ongoing evaluation and management of patients for a brief period of time for well-defined conditions. We describe the implementation of a paediatric observation unit (POU) adjacent to a paediatric emergency department (PED) in an urban, academic, community hospital.MethodsStaffing models were designed to provide paediatric services to patients in both the PED and POU. Admission criteria, workflow and transfer guidelines were developed. Quality improvement initiatives were undertaken and evaluated. Unit throughput, patient outcomes and patient satisfaction data were collected and analysed.ResultsOver a 2-year period, there were 24 038 patient visits to the PED. Of these, 1215 (5.1%) patients required admission. Seven hundred and seventy-seven (64.0%) of these children were admitted to the POU. One hundred and nineteen (15.3%) of these patients were subsequently converted to inpatient hospitalisation. The average length of stay (LOS) was 25.7 hours in 2017 and 26.5 hours in 2018. Ten patients returned to the PED within 72 hours of discharge from the POU and four were readmitted. Patient satisfaction scores regarding ‘likelihood to recommend’ improved from the 36th to the 92nd percentile rank over a 1-year period. Close monitoring of patient outcomes allowed for the adjustment of admission guidelines, increased unit census and optimised utilisation.ConclusionA combined PED-POU has been successful at our institution in meeting benchmark goals set for LOS and conversion rates. In addition, quality improvement interventions increased patient census and improved patient satisfaction scores while reducing the inpatient burden on the referring children’s hospital.

scholarly journals Residual gastric volume evaluation with ultrasonography after ingestion of carbohydrate- or carbohydrate plus glutamine-enriched beverages: a randomized, crossover clinical trial with healthy volunteers

2017 ◽  
Vol 54 (1) ◽  
pp. 33-36 ◽  
Author(s):  
Paulo Cesar GOMES ◽  
Cervantes CAPOROSSI ◽  
Jose Eduardo AGUILAR-NASCIMENTO ◽  
Ageo Mario Candido da SILVA ◽  
Viviane Maeve Tavares de ARAUJO
Keyword(s):  
Clinical Trial ◽  
Healthy Volunteers ◽  
Postoperative Recovery ◽  
Gastric Volume ◽  
Safe Procedure ◽  
Abdominal Ultrasonography ◽  
Residual Gastric Volume ◽  
Potential Benefits ◽  
The Mean ◽  
To Receive

ABSTRACT BACKGROUND Abbreviation of preoperative fasting to 2 hours with maltodextrin (CHO)-enriched beverage is a safe procedure and may enhance postoperative recovery. Addition of glutamine (GLN) to CHO beverages may include potential benefits to the metabolism. However, by adding a nitrogenous source to CHO beverages, gastric emptying may be delayed and increase the risk of bronchoaspiration during anesthesia. OBJECTIVE In this study of safety, we aimed at investigating the residual gastric volume (RGV) 2 hours after the intake of either CHO beverage alone or CHO beverage combined with GLN. METHODS We performed a randomized, crossover clinical trial. We assessed RGV by means of abdominal ultrasonography (US) in 20 healthy volunteers (10 males and 10 females) after an overnight fast of 8 hours. Then, they were randomized to receive 600 mL (400 mL immediately after US followed by another 200 mL 2 hours afterwards) of either CHO (12.5% maltodextrin) or CHO-GLN (12.5% maltodextrin plus 15 g GLN). Two sequential US evaluations were done at 120 and 180 minutes after ingestion of the second dose. The interval of time between ingestion of the two types of beverages was 2 weeks. RESULTS The mean (SD) RGV observed after 8 hours fasting (13.56±13.25 mL) did not statistically differ (P>0.05) from the RGV observed after ingesting CHO beverage at both 120 (16.32±11.78 mL) and 180 minutes (14.60±10.39 mL). The RGV obtained at 120 (15.63±18.83 mL) and 180 (13.65±10.27 mL) minutes after CHO-GLN beverage also was not significantly different from the fasting condition. CONCLUSION The RGV at 120 and 180 minutes after ingestion of CHO beverage combined with GLN is similar to that observed after an overnight fast.

Solumedrol Treatment for Severe Sepsis in Humans with a Blunted Adrenocorticotropic Hormone-Cortisol Response: A Prospective Randomized Double-Blind Placebo-Controlled Pilot Clinical Trial

2021 ◽  
pp. 088506662110388
Author(s):  
Divya Birudaraju ◽  
Sajad Hamal ◽  
John A. Tayek
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Adrenocorticotropic Hormone ◽  
Serum Cortisol ◽  
High Dose ◽  
Cortisol Response ◽  
Acth Stimulation ◽  
Double Blind ◽  
Significant Difference ◽  
To Receive

Purpose To test the benefits of Solumedrol treatment in sepsis patients with a blunted adrenocorticotropic hormone (ACTH)-cortisol response (delta <13 µg/dL) with regard to the number of days on ventilator, days on intravenous blood pressure support, length of time in an intensive care unit (ICU), 14-day mortality, and 28-day mortality. The trial was prospective, randomized, and double-blind. As part of a larger sepsis trial, 54 patients with sepsis had an intravenous ACTH stimulation test using 250 µg of ACTH, and serum cortisol was measured at times 0, 30, and 60 min. Eleven patients failed to increase their cortisol concentration above 19.9 µg/dL and were excluded from the clinical trial as they were considered to have adrenal insufficiency. The remaining 43 patients had a baseline cortisol of 32 ± 1 µg/dL increased to 38 ± 3 µg/dL at 30 min and 40 ± 3 at 60 min. All cortisol responses were <12.9 µg/dL between time 0 and time 60, which is defined as a blunted cortisol response to intravenous ACTH administration. Twenty-one were randomized to receive 20 mg of intravenous Solumedrol and 22 were randomized to receive a matching placebo every 8 h for 7-days. There was no significant difference between the two randomized groups. Data analysis was carried out bya two-tailed test and P < .05 as significant. Results Results: The mean age was 51 ± 2 (mean ± SEM) with 61% female. Groups were well matched with regard to APACHE III score in Solumedrol versus placebo (59 ± 6 vs 59 ± 6), white blood cell count (18.8 ± 2.2 vs 18.6 ± 2.6), and incidence of bacteremia (29 vs 39%). The 28-day mortality rate was reduced in the Solumedrol treated arm (43 ± 11 vs 73 ± 10%; P < .05). There was no change in days in ICU, days on blood pressure agents, or days on ventilator. Seven days of high-dose intravenous Solumedrol treatment (20 mg every 8 h) in patients with a blunted cortisol response to ACTH was associated with an improved 28-day survival. This small study suggests that an inability to increase endogenous cortisol production in patients with sepsis who are then provided steroid treatment could improve survival.

scholarly journals Patient Satisfaction Scores and Their Relationship to Hospital Website Quality Measures

2013 ◽  
Vol 30 (4) ◽  
pp. 334-348 ◽  
Author(s):  
Eric W. Ford ◽  
Timothy R. Huerta ◽  
Mark L. Diana ◽  
Abby Swanson Kazley ◽  
Nir Menachemi
Keyword(s):  
Patient Satisfaction ◽  
Quality Measures ◽  
Website Quality ◽  
Patient Satisfaction Scores

scholarly journals Effect of Red Wine Intake on Serum and Salivary Melatonin Levels: A Randomized, Placebo-Controlled Clinical Trial

Molecules ◽  
2018 ◽  
Vol 23 (10) ◽  
pp. 2474 ◽  
Author(s):  
Elena Varoni ◽  
Rita Paroni ◽  
Jacopo Antognetti ◽  
Giovanni Lodi ◽  
Andrea Sardella ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthy Volunteers ◽  
Red Wine ◽  
Statistical Significance ◽  
Serum Levels ◽  
Controlled Clinical Trial ◽  
Salivary Melatonin ◽  
The One ◽  
To Receive

Melatonin (MLT) is a recently discovered phytochemical in wine, but its influence on physiological MLT levels is still unknown. This study aimed at evaluating variations, in serum and saliva, of MLT concentrations after the intake of MLT-enriched red wine. Twelve healthy volunteers were recruited to receive 125 mL of red wine naturally lacking of MLT (placebo, PLC), or the same wine enriched with MLT (MLT+). A physiological steady decline of serum MLT was observed from baseline up to 90 min, for both wines. After PLC intake, the decrease was significantly faster than the one occurring after MLT+ wine, which thus delayed the drop down of serum MLT with a plateau at 30–60 min. Salivary MLT levels slightly peaked at 45 min after MLT+ wine intake, without statistical significance. Therefore, the intake of a glass of MLT-enriched red wine changed serum levels of the indoleamine, supporting the role of wine MLT in counteracting the physiological decline of the hormone into the bloodstream.

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